The Nonequivalent “Equivalent Cutoff”

Newborn screening of lysosomal storage disorders (LSDs) can be performed using different methods, workflows, screening algorithms, assay protocols, reagents/kits and instruments, all of which impact the output of the test. “Equivalent cutoff” has been proposed as a method to normalize screening results across LSD screening platforms. In this white paper, we review the validity of the recently proposed “equivalent cutoff” and the critical shortcomings in the effectiveness of this idea, including how it ignores the cardinal rule of newborn screening:
to minimize the chance of a false negative result.

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